INVAC-1 Anti-Cancer hTERT DNA Immunotherapy

NCT02301754 | Completed Phase 1 DMC

• 1 other identifier: INVAC1-CT-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

INVAC-1 is intended to be used for the treatment of adult patients with advanced solid tumors unresponsive to currently available therapies, or for whom no standard therapy is available.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities (DLTs) of INVAC-1 as single agent in combination with electroporation

  up to 28 days after last injection

Secondary Outcomes (11)

• Adverse Events as characterized by type, frequency, severity (as graded by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.03), timing, seriousness and relationship to study therapy INVAC-1 + electroporation;

  up to 28 days after last injection

• Routine laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03) and timing

  up to 28 days after last injection

• Tumor Necrosis Factor-α, Interleukine (IL)-17, IL-8, IL-6, IL-1β measured in serum

  up to 28 days after last injection

• anti-nuclear antibodies (ANA), anti-DNA, anti-TPO measured in serum

  up to 28 days after last injection

• Elispot Interferon gamma

  every 4 weeks up to 3 months

Study Arms (1)

INVAC-1

EXPERIMENTAL

INVAC-1 at escalating doses of 100, 400 and 800 µg will be given as a single agent by intradermal injection (Q 4 weeks x 3 cycles), always combined with electroporation. Each patient will receive 3 cycles, unless motivated treatment interruption.

Biological: INVAC-1

Interventions

INVAC-1 BIOLOGICAL

intradermal injection combined with electroporation

INVAC-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of advanced/metastatic solid tumor malignancy
• Relapsed or refractory to standard treatment and for whom standard curative options do not exist
• Life-expectancy \> 4 months
• Age 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• A delay of at least 3 weeks between last specific anticancer treatment and first INVAC-1 injection
• Adequate skin status
• Lack of biologically documented inflammation: C Reactive Protein \< 15 mg/L
• No medical history of auto-immune disease
• Adequate bone marrow function
• Total white cells count ≤ 10 x 109/L (≤ 10,000/µL),
• Serum albuminemia \> 30 g/L
• Adequate renal function, with an estimated creatinine clearance ≥ 50 mL/min as calculated using the Cockroft \& Gault method
• Adequate liver function
• Adequate cardiac function

You may not qualify if:

• Central Nervous System (CNS) primary or CNS metastatic malignancies
• Prior allogeneic hematopoietic stem cell transplant
• Chemotherapy, cancer immunosuppressive therapy, growth factors, systemic steroids, or investigational agents within 28 days before the first dose of study treatment
• Prior therapy with a compound of the same mechanism (immunomodulation) in the last 90 days prior to first dose of study drug
• Participation to a clinical trial of an experimental medication in the last 30 days prior to first dose of study drug
• Major surgery within 28 days of starting study treatment
• Radiation therapy within 28 days of starting study treatment
• Autoimmune disorders (eg, Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus) and other diseases that compromise or impair the immune system.
• Contra-indications to electroporation: cardiac pacemaker, any previous cardiac rhythm disorder, epilepsy.
• Active and clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness (HIV testing is not required).
• Unstable or serious concurrent medical conditions in the previous 12 months.
• Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
• Patients who are pregnant or breastfeeding.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality.
• Patients who are investigational site staff members or patients who are Invectys employees directly involved in the conduct of the trial.

Sponsors & Collaborators

• Invectys: lead
• Keyrus Biopharma: collaborator

Study Sites (2)

Hôpital Saint Louis

Paris, 75010, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

• Teixeira L, Medioni J, Garibal J, Adotevi O, Doucet L, Durey MD, Ghrieb Z, Kiladjian JJ, Brizard M, Laheurte C, Wehbe M, Pliquet E, Escande M, Defrance R, Culine S, Oudard S, Wain-Hobson S, Doppler V, Huet T, Langlade-Demoyen P. A First-in-Human Phase I Study of INVAC-1, an Optimized Human Telomerase DNA Vaccine in Patients with Advanced Solid Tumors. Clin Cancer Res. 2020 Feb 1;26(3):588-597. doi: 10.1158/1078-0432.CCR-19-1614. Epub 2019 Sep 26.

  PMID: 31558479 DERIVED

Study Officials

• Stéphane Culine, MD

  Hopital St Louis - Paris - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 26, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

FR (2)